Sacral Neuromodulation for Chronic Pelvic Pain

(SNM_CPP Trial)

Recruiting at 1 trial location

Overseen By Jennifer Giordano, BSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Disqualifiers: Pelvic cancer, Severe diabetes, Interstitial cystitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not change your medication regimen for pelvic pain for more than 4 weeks before screening. You also cannot start any new treatments for chronic pelvic pain before a certain point in the study.

What data supports the effectiveness of the treatment Sacral Neuromodulation for Chronic Pelvic Pain?

Sacral neuromodulation (SNM) is an established treatment for functional disorders of the pelvic organs, and it is gaining popularity for chronic pelvic pain (CPP). A meta-analysis and systematic review suggest that SNM is effective in improving CPP. ^{1 2 3 4 5}

Is sacral neuromodulation generally safe for humans?

Sacral neuromodulation (SNM) is considered a safe therapy for managing conditions like fecal and urinary incontinence, with over 350,000 devices implanted since FDA approval in 1998. While the technology has evolved, safety updates have been minimal, indicating a stable safety profile over time. ^{1 2 3 4 6}

How is sacral neuromodulation different from other treatments for chronic pelvic pain?

Sacral neuromodulation is unique because it involves a minimally invasive procedure that stimulates the sacral spinal nerves to manage chronic pelvic pain, unlike other treatments that may rely on medication or surgery. It is particularly useful for patients who do not respond to conservative treatments and offers an alternative to radical surgery. ^{1 2 5 7 8}

What is the purpose of this trial?

Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.

Research Team

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Eligibility Criteria

Women aged 22-70 with chronic pelvic pain who've tried at least one treatment without success can join. They mustn't change their pain meds for 4 weeks before the trial, use effective birth control, and commit to the study's duration. Exclusions include pelvic cancer history, severe medical conditions that could affect results, certain concurrent pain treatments, psychiatric disorders as judged by the physician (except stable depression or anxiety), frequent UTIs, uncontrolled diabetes with nerve issues, prior SNM device or trial participation, allergies to specific materials in the device components (titanium etc.), spinal cord stimulators/drug pumps implanted regardless of status (on/off), breastfeeding or pregnant women not using contraception properly.

Inclusion Criteria

I have tried at least one non-surgical treatment without success.

I am willing and able to follow all study rules and attend all appointments.

Provision of signed and dated informed consent form

Exclusion Criteria

My diabetes is severe or uncontrolled, or affects my nerves.

Subject with documented history of allergy to titanium, zirconia, polyurethane, epoxy, or silicone

I am currently being treated for cancer, not including skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation

Sacral neuromodulation device is implanted and initial settings are adjusted

1 day

1 visit (in-person, operating room)

Post-Operative Adjustment

Device settings are adjusted and participants complete study questionnaires

2 weeks

1 visit (in-person)

Treatment

Participants receive ongoing sacral neuromodulation with device settings adjusted as needed

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sacral Neuromodulation

Trial Overview The trial is testing sacral neuromodulation—a minimally invasive procedure where a small device is implanted—to see if it helps women suffering from chronic pelvic pain. The effectiveness will be measured throughout the study period after a single implantation procedure.

Participant Groups

Group I: SNM for the treatment of CPP Experimental Treatment 1 Intervention

Patients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7.

Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence

Approved in European Union as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Approved in Canada as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Findings from Research

Sacral neuromodulation (SNM) with the InterStim II system has evolved into a minimally invasive procedure, significantly improving treatment success rates for chronic urinary and bowel dysfunction, with a response rate of approximately 80%.

Recent advancements, such as the tined lead and smaller neurostimulator, have enhanced patient comfort, reduced technical failures, and improved quality of life, making SNM a viable option for patients who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Spinelli, M., Sievert, KD.[2008]

The median lifespan of the InterStim™ and InterStim™ II devices used for sacral nerve neuromodulation is 7.29 years and 5.9 years, respectively, indicating that the newer model has a shorter lifespan than the original.

The shorter lifespan of the InterStim™ II is linked to increased long-term hospital costs, suggesting that while both devices are effective for managing incontinence, the choice of device may impact overall treatment expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. Daikh, A., Reymond, F., Lombardo, D., et al.[2023]

A review of over 44,000 adverse event reports related to sacral neuromodulation (SNM) devices found that many reported complications (43.2%) were not true adverse events but rather issues related to device use and the need for better technical support.

The low number of lawsuits (only four identified) over 24 years suggests that SNM devices have a strong safety profile, with complications often stemming from inappropriate patient selection or lack of follow-up rather than device malfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database. Carlton, CE., Souders, CP., Chertack, NA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sacral Neuromodulation: Standardized Electrode Placement Technique. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Repeatability of tools to assist in the follow up and troubleshooting of sacral neuromodulation patients using the sensory response. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. [2008]

4. Germany pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation treating chronic pelvic pain: a meta-analysis and systematic review of the literature. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation as a treatment for chronic pelvic pain. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Efficacy of sacral neuromodulation in treating chronic pain related to painful bladder syndrome/interstitial cystitis in adults. [2021]